Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. PET/CT Computed tomography systems.
FDA Recall Z-0013-2007 · Posted 2007-09-26
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Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2006-11-06
Date Terminated2010-10-05
Product Quantity70
Reason for Recall
A potential anomaly was identified on the CT subsytem, which could result in the radiation dose being different than the calculated dose reported to the operator.
Firm Action
The customers were sent Public Safety Notification November 3, 2006, indicating there was a problem with the software. However, since their unit was recently upgraded the problem did not impact their unit.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Australia, Canada, China, England, Finland, France, Germany, Ireland, Israel, Italy, Japan, Jordan, Korea, Netherlands, Poland, Puerto Rico, Spain, and Taiwan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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